Methods for applying surgical staples to internal walls of hollow tissue organs

ABSTRACT

A method of performing a surgical anastomosis is disclosed. The method includes providing an anastomotic device including a fluid supply channel extending between a handle assembly and a head assembly. The method also includes positioning the head assembly of the anastomotic device adjacent a hollow tissue organ, inserting the head assembly of the anastomotic device into the hollow tissue organ, and discharging an inflation fluid through at least one fluid outlet and into the hollow tissue organ to insufflate at least a portion of the hollow tissue organ.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/011,103 filed Aug. 27, 2013, which claims benefit of and priority toU.S. Provisional Application No. 61/698,148 filed Sep. 7, 2012, and thedisclosures of each of the above-identified applications are herebyincorporated by reference in their entirety.

BACKGROUND

Technical Field

The present disclosure relates generally to methods for applyingsurgical staples to body tissue. More particularly, the presentdisclosure relates to an anastomotic device suitable for performingcircular anastomosis and/or treatment to internal walls of hollow tissueorgans.

Background of Related Art

Anastomosis is the surgical joining of separate hollow organ sections.Typically, an anastomosis procedure follows surgery in which a diseasedor defective section of hollow tissue is removed and the remaining endsections are to be joined. Depending on the desired anastomosisprocedure, the end sections may be joined by either circular,end-to-end, or side-to-side organ reconstruction methods.

In a circular anastomosis procedure, the two ends of the organ sectionsare joined by means of a stapling instrument which drives a circulararray of staples through the end section of each organ section and coresany tissue within the driven circular array of staples to free thetubular passage. Examples of instruments for performing circularanastomosis of hollow organs are described in U.S. Pat. Nos. 6,053,390,5,588,579, 5,119,983, 5,005,749, 4,646,745, 4,576,167, and 4,473,077,each of which is incorporated herein in its entirety by reference.Typically, these instruments include an elongated shaft having a handleportion at a proximal end to actuate the instrument and a staple holdingcomponent (e.g., a cartridge assembly) disposed at a distal end. Ananvil assembly including an anvil rod with attached anvil head ismounted to the distal end of the instrument adjacent the staple holdingcomponent. Opposed end portions of tissue of the hollow organ(s) to bestapled are clamped between the anvil head and the staple holdingcomponent. The clamped tissue is stapled by driving one or more staplesfrom the staple holding component so that the ends of the staples passthrough the tissue and are deformed by the anvil head. An annular knifeis advanced to core tissue within the hollow organ to free a tubularpassage within the organ.

Besides anastomosis of hollow organs, surgical stapling devices forperforming circular anastomosis have been used to treat internalhemorrhoids in the rectum. Typically, during use of a circular staplingdevice for hemorrhoid treatment, the anvil head and the staple holdingcomponent of the surgical stapling device are inserted through the anusand into the rectum with the anvil head and the staple holding componentin an open or unapproximated position. Thereafter, a pursestring sutureis used to pull the internal hemorrhoidal tissue towards the anvil rod.Next, the anvil head and the staple holding component are approximatedto clamp the hemorrhoid tissue between the anvil head and the stapleholding component. The stapling device is fired to remove thehemorrhoidal tissue and staple the cut tissue.

SUMMARY

The present disclosure relates to a method of performing a surgicalanastomosis. The method comprises providing an anastomotic deviceincluding a handle assembly, an elongated body portion extendingdistally from the handle assembly, a head assembly and a fluid supplychannel. The head assembly is disposed adjacent a distal portion of theelongated body portion, and includes an anvil assembly and a cartridgeassembly. The fluid supply channel extends between the handle assemblyand the head assembly. At least one fluid outlet is disposed at a distalend of the fluid supply channel. The method further comprisespositioning the head assembly of the anastomotic device adjacent ahollow tissue organ, inserting the head assembly of the anastomoticdevice into the hollow tissue organ, and discharging an inflation fluidthrough the at least one fluid outlet and into the hollow tissue organto insufflate at least a portion of the hollow tissue organ.

In disclosed embodiments, discharging an inflation fluid comprisesdischarging the inflation fluid through the at least one fluid outletand into an intestine to insufflate a rectal stump. It is furtherdisclosed to discharge the inflation fluid through the at least onefluid outlet and into the hollow tissue organ while inserting the headassembly of the anastomotic device into the hollow tissue organ. It isfurther disclosed to move the head assembly distally beyond a sphinctermuscle, and to discharge the inflation fluid through the at least onefluid outlet and into the hollow tissue after the head assembly of theanastomotic device has been moved distally beyond the sphincter muscle.

In disclosed embodiments, discharging an inflation fluid comprisesdischarging between about 0.60 oz and about 17.0 oz of the inflationfluid through the at least one fluid outlet. It is also envisioned todischarge between about 1.0 oz and about 11.0 oz of the inflation fluidthrough the at least one fluid outlet.

In disclosed embodiments, the cartridge assembly includes staplestherein, and the method further comprises ejecting staples from thecartridge assembly toward the anvil assembly and creating a staple linein the hollow tissue organ.

In disclosed embodiments, discharging an inflation fluid comprisesdischarging the inflation fluid through the at least one fluid outlet ata rate in the range of between about 00.01 oz/s and about 0.70 oz/s. Itis also envisioned to discharge between about 0.03 oz/s and about 0.34oz/s of the inflation fluid through the at least one fluid outlet.

In disclosed embodiments, discharging an inflation fluid comprisesdischarging the inflation fluid through the at least one fluid outlet ata distal face of the cartridge assembly. It is further envisioned todischarge the inflation fluid through the at least one fluid outletwhile a retaining pin, which interconnects the cartridge assembly andanvil assembly, is in a fully retracted position. It is also envisionedto discharge the inflation fluid through the at least one fluid outletat a distal end of a guide lumen arranged concentric to the cartridgeassembly.

In disclosed embodiments, the anastomotic device includes a knifedisposed at least partially within the head assembly, and the methodfurther comprises advancing the knife to cut tissue of the hollow tissueorgan. It is envisioned that the inflation fluid is discharged throughthe at least one fluid outlet at an annular space between the knife anda lateral wall of the head section.

DESCRIPTION OF THE DRAWINGS

Embodiments of a surgical stapling device and method of use aredisclosed herein with reference to the drawings, wherein:

FIG. 1 is a side view of an anastomotic device according to embodimentsof the present disclosure; and

FIGS. 2-4 are cross-sectional views of a head section of the anastomoticdevice of FIG. 1 in accordance with various embodiments of the presentdisclosure.

DETAILED DESCRIPTION

Embodiments of the presently disclosed anastomotic device will now bedescribed in detail with reference to the drawings wherein like numeralsdesignate identical or corresponding elements in each of the severalviews. As is common in the art, the term “proximal” refers to that partor component closer to the user or operator, i.e. surgeon or physician,while the term “distal” refers to that part or component farther awayfrom the user.

FIG. 1 illustrates an embodiment of an anastomotic device according tothe present disclosure, referenced generally as reference numeral 1.Anastomotic device 1 is configured for forming an anastomosis, e.g., anintestinal anastomosis. Anastomotic device 1 includes a handle assemblyor actuating part 4, an elongated body portion or introducer sheath 2extending distally from actuating part 4, and a shell assembly or headsection 3 mounted adjacent a distal end of introducer sheath 2.Actuating part 4 includes a fixed handle and a moveable handle, triggeror operating grip 14. Actuating part 4 also includes an approximationknob or adjusting screw 13 for moving a thrust bearing part, anvilsection or anvil assembly 6 relative to a cartridge assembly of headsection 3. A head assembly includes anvil assembly 6 and the cartridgeassembly.

Head section 3 includes a distal hollow-cylindrical head section 5,which houses a clamping mechanism (or stapling mechanism) and aplurality of staples. During clamping or stapling, the clamps or staples(not shown) of head section 3 are moved toward anvil assembly 6.Additionally, an annular or ring-shaped extendable and retractable knife7 and a retaining pin 8 are arranged within head section 3. Retainingpin 8 can be extended and retracted into head section 3. Knife 7 andretaining pin 8 are arranged concentrically within hollow-cylindricalhead section 5, and retaining pin 8 is arranged centrically in headsection 3 within a sleeve 22. With reference to FIGS. 2-4, knife 7 isshown mechanically engaged with a pusher part 24. Pusher part 24includes two guide webs 26 a, and additional guide webs 26 b that extendradially outward from sleeve 22.

As shown in FIG. 1, retaining pin 8 is connectable to a shaft orvertical passageway 10 of anvil assembly 6. Further, shaft 10 isconnected to and extends proximally from an anvil 11 of anvil assembly6. On a proximal side of anvil 11 (i.e., the side facing head section3), anvil 11 includes a circular anvil surface 12 with staple-formingpockets. The connection of retaining pin 8 and anvil assembly 6 can takeplace by snapping retaining pin 8 into shaft 10, for example.

Retaining pin 8 is extended and retracted by turning adjusting screw 13at the proximal end of actuating part 4. Actuation of operating grip 14causes the stapling mechanism to be actuated and causes distaladvancement of knife 7.

It is disclosed that anastomotic device 1 is used for producing anintestinal anastomosis. After removing a diseased part of the largeintestine, for example, it is necessary to join the remaining proximalportion and the distal portion of the large intestine. During such aprocedure, anvil assembly 6 is positioned into a first portion of thelarge intestine. This portion of the large intestine surrounds anvil 11,while shaft 10 extends proximally from this portion of the largeintestine. Subsequently, anastomotic device 1 is inserted, withretaining pin 8 in a retracted position, through the anus and pushed toa second portion of the intestine that has been sealed. Then, retainingpin 8 is extended to an extended position (as shown in FIG. 1) andpunctures the second portion of the intestine (e.g., a sutured portion).

After connecting retaining pin 8 with shaft 10 of anvil assembly 6,anvil assembly 6 is moved proximally by retracting retaining pin 8 intohead section 3 until the first and second portions of the intestine lieclose together. The stapling mechanism is then activated, such that thestaples are ejected from a circular front surface 15 of head section 5and are moved against the facing circular anvil surface 12 causingdeformation of the staples such that the two intestine portions areinterconnected. Actuation of operating grip 14 also causes knife 7 toextend from head section 3 to separate tissue located between headsection 3 and anvil assembly 6. After tissue is stapled and cut,anastomotic device 1 can then be retracted from the body through theanal canal, for example. DE 10 2007 057 207 A1 discloses a method withthe features as described above and a clamp inserter.

Deviating from the clamp inserter as known from DE 10 2007 057 207 A1,anastomotic device 1, as shown in FIG. 1, is configured to deliver aninflation fluid, such as liquid 19, via a fluidic connection betweenactuating part 4 and head section 3 into the body lumen and thus, effectan inflation or insufflation of the body tissue. One of skill in the artwill recognize that inflation fluid may comprise a liquid or a gas, orany combination thereof. Filling the body lumen with inflation liquid 19causes an increase in volume, which facilitates a friction-free and aninjury-free insertion of anastomotic device 1 into the body lumen, forexample through the anal canal into a portion of the large intestine.Additionally, inflating the body lumen can be helpful prior toconducting an anastomosis in providing a leak test of sutured tissue. Itis envisioned that using a colored inflation liquid will allow a visualcontrol during insertion of anastomotic device 1 and during the leaktest of the suture, wherein it is determined whether and to what extenta liquid has penetrated the suture.

Anastomotic device 1 of the present disclosure includes at least onefluid outlet disposed at the end (e.g., a distal end) of fluid supplychannel 16. The configuration of the fluidic connection allows inflationliquid 19 to be discharged from anastomotic device 1 during insertion ofhead section 3 into the body lumen, for example. It is further disclosedthat during an intestinal anastomosis, inflation liquid 19 can bedischarged from anastomotic device 1 after a distal boundary region 18of head section 3 has passed the sphincter muscle, and/or when pushingintroducer sheath 2 distally.

As shown in FIG. 1, inflation liquid 19 can be delivered when at least aportion of retaining pin 8 is extended distally beyond head section 3.Because the retaining pin 8 is typically fully retracted into headsection 3 during insertion of anastomotic device 1 into the body lumen,the fluidic connection is also configured for the delivery of inflationliquid 19 into the body lumen when retaining pin 8 is partially and/orcompletely retracted. In the retracted condition, the distal tip ofretaining pin 8 is arranged inside the head section 3.

The delivery of inflation liquid 19 into the body lumen via circularfront surface 15 of head section 5 or a distal face of head section 3can be helpful, for example, to inflate a collapsed body lumen. It isenvisioned that inflation liquid 19 is delivered into the intestine toinsufflate the rectal stump. It is further envisioned that inflationliquid 19 is delivered through the fluid outlet(s) and into the hollowtissue organ while inserting the head assembly (e.g., head section 3) ofanastomotic device 1 into the hollow tissue organ.

With particular reference to FIG. 2, retaining pin 8 is positionedwithin a guide lumen 21 arranged concentric to head section 3. In thisembodiment, inflation liquid 19 exits through a fluid outlet at thedistal end of guide lumen 21. In the illustrated embodiment, the radialinner boundary of guide lumen 21 is retaining pin 8, and the radialouter boundary of guide lumen 21 is sleeve 22.

An alternative embodiment of anastomotic device 1 is shown in FIG. 3.Here, the delivery of inflation liquid 19 takes place throughstaple-receiving pockets or clamp outlets 23 of the stapling mechanismin circular front surface 15 of head section 5. It is further envisionedthat additional fluid outlets (not shown) may be provided in frontsurface 15, so that the liquid delivery does not take place throughclamp outlets 23.

Another alternative embodiment of anastomotic device 1 is shown in FIG.4. Here, the delivery of inflation liquid 19 takes place through fluidoutlets 17 in the annular space between knife 7 and sleeve 22. It isfurther envisioned that inflation liquid 19 can be delivered throughfluid outlets 17 in side walls of pusher part 24. Alternatively and/oradditionally, inflation liquid 19 can be delivered through gaps betweenthe side walls of pusher part 24 and sleeve 22 and/or guide webs 26 b.

It is further envisioned that a lateral portion of head section 3, e.g.,within distal boundary region 18, include one or more fluid outletswhich may be evenly distributed in a circumferential direction. Here,inflation liquid 19 can be delivered through a distal lateral surface 5a (FIG. 1) of head section 5.

In the disclosed embodiments including more than one fluid outlet, it isenvisioned that a distal portion of fluid supply channel 16 branches offinto the fluid outlets.

Additionally, and as shown in FIG. 1, a hose 25 extends from actuatingpart 4 and is connected to and/or forms a proximal portion of fluidsupply channel 16. It is envisioned that hose 25 is connected to areservoir (not shown) containing inflation liquid 19. In the illustratedembodiment, hose 25 includes a screw-type cap 26 at its free end, sothat it is possible after unscrewing screw-type cap 26 to injectinflation liquid 19 into hose 25 with a syringe or the like. A syringemay be further used to force inflation liquid 19 through fluid supplychannel 16, toward head section 3, and out of the fluid outlet(s) (e.g.,fluid outlets 17). It is further envisioned that a three-way connectionis provided to facilitate the supply of different liquids through hose25 and fluid supply channel 16.

It is envisioned that between about 0.60 oz and about 17.0 oz ofinflation liquid 19 is discharged through the fluid outlet(s). Inembodiments, between about 1.0 oz and about 11.0 oz of inflation liquid19 is discharged through the fluid outlet(s). It is further envisionedthat the amount of inflation liquid 19 that is used is at leastpartially determined by the bursting pressure of the hollow tissue organ(e.g., within or adjacent a rectal stump) near the staple line, suchthat the amount of inflation liquid 19 used does not cause the pressurein the hollow tissue organ near the staple line to exceed the burstingpressure. The use of a pressure sensor or other conventional methods canbe used to determine the actual pressure.

It is further envisioned that inflation liquid 19 is discharged throughthe fluid outlet(s) at a rate of between about 0.01 oz/s and about 0.70oz/s. In embodiments, inflation liquid 19 is discharged through thefluid outlet(s) at a rate of between about 0.03 oz/s and about 0.34oz/s.

It is further envisioned that anastomotic device 1 is inserted intoand/or retracted from the body lumen at a rate of between about 0.03in/s and about 4.0 in/s. In embodiments, anastomotic device 1 isinserted into and/or retracted from the body lumen at a rate of betweenabout 0.10 in/s and about 2.0 in/s.

Persons skilled in the art will understand that the various apparatus,and corresponding methods of use described herein, and shown in theaccompanying drawings, constitute non-limiting, exemplary embodiments ofthe present disclosure, and that additional components and features maybe added to any of the embodiments discussed herein above withoutdeparting from the scope of the present disclosure.

Additionally, persons skilled in the art will understand that theelements and features shown or described in connection with oneexemplary embodiment may be combined with those of another embodimentwithout departing from the scope of the present disclosure, and willappreciate further features and advantages of the presently disclosedsubject matter based on the above-described embodiments and the claims.Accordingly, the present disclosure is not limited by what has beenparticularly shown and described.

The invention claimed is:
 1. An anastomotic device, comprising: a handleassembly; an elongated body portion extending distally from the handleassembly and defining a longitudinal axis; a head assembly disposedadjacent a distal portion of the elongated body portion, the headassembly including an anvil assembly and a cartridge assembly; aretaining member extending at least partially through the cartridgeassembly and being configured to mechanically engage the anvil assembly;a guide lumen disposed at least partially within the cartridge assembly,at least a portion of the retaining member is disposed within at least aportion of the guide lumen; a channel extending between the handleassembly and a portion of the head assembly, a portion of the channelbeing in fluid contact with the guide lumen; an annular knife disposedat least partially within the head assembly, the annular knife beinglongitudinally movable with respect to the cartridge assembly; anannular space defined between the annular knife and a lateral wall ofthe head assembly; and at least one outlet disposed adjacent a distalend of the channel, in the annular space, and in contact with the guidelumen.
 2. The anastomotic device according to claim 1, wherein the anvilassembly is longitudinally movable with respect to the cartridgeassembly.
 3. The anastomotic device according to claim 1, wherein thecartridge assembly includes staples therein.
 4. The anastomotic deviceaccording to claim 1, wherein the at least one outlet is disposed on adistal face of the cartridge assembly.
 5. The anastomotic deviceaccording to claim 1, wherein the retaining member is proximally anddistally movable with respect to the cartridge assembly.
 6. Theanastomotic device according to claim 1, where a first boundary of theguide lumen is the retaining member.
 7. The anastomotic device accordingto claim 6, wherein the first boundary of the guide lumen is a radialinner boundary.
 8. The anastomotic device according to claim 7, whereina radial outer boundary of the guide lumen is a sleeve.
 9. Theanastomotic device according to claim 8, wherein the sleeve is theclosest wall of the head assembly to the retaining member.
 10. Theanastomotic device according to claim 6, wherein a second boundary ofthe guide lumen is a sleeve.
 11. The anastomotic device according toclaim 10, wherein the sleeve is the closest wall of the head assembly tothe retaining member.